STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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Model Number 6260-9-236 |
Device Problems
Detachment of Device or Device Component (2907); Osseointegration Problem (3003)
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Patient Problems
Pain (1994); Inadequate Osseointegration (2646)
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Event Date 03/27/2023 |
Event Type
Injury
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Event Description
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It was reported, "this pi is for: symax stem with worn conus and loose head.".Abgii stem with worn conus and loose head.Symax stem with worn conus and loose head.
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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It was reported, "this pi is for: symax stem with worn conus and loose head." abgii stem with worn conus and loose head.Symax stem with worn conus and loose head.
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Manufacturer Narrative
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An event regarding disassociation involving a metal head was reported.The event was confirmed via evaluation of the returned devices.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned devices indicated that damage consistent with the loss of taper lock was observed on the head and stem.Material analysis: damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.No further material analyses were performed.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to wear of the stem and loss of taper lock.Visual inspection of the returned devices indicated damage consistent with the loss of taper lock on the head and stem.The subject device has been identified to be within scope of an nc and capa.Lot specific voluntary recall ra 2016-028 was initiated for the lfit v40 cocr heads within scope of said nc and capa.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before march 4, 2011.The root cause analyses identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.No further investigation is required.
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